Further study details as provided by CardioVascular BioTherapeutics, Inc.:

Primary Outcome Measures:

Safety [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

The main objective of this study is to evaluate the safety and tolerability of FGF-1 in patients with peripheral arterial disease and intermittent claudication. Vital signs, physical examinations, safety laboratory evaluations and total number of adverse events will be captured and analyzed accordingly.

FGF-1 administered by intramuscular injection for the treatment of peripheral arterial disease with intermittent claudication. Eligible patients are allocated to one of three treatment arms. Patients within each dosing group will be randomized between study drug and vehicle control. Safety, pharmacokinetics, and cardiovascular improvement will be evaluated at day 1 and weeks 1, 4 and 12 post dosing.

Eligibility

Ages Eligible for Study:

50 Years to 75 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria

Subjects considered eligible to enter the study must sign an informed consent form prior to the initiation of any study procedures. In the event that the subject must be withdrawn and is re-screened for study participation at a later date, a new informed consent form must be signed. Subjects must be competent to give written informed consent.

Age must be ≥50 and ≤75 years of age with a life expectancy of > 1 year and leg survival > 6 months. Patients >75 and ≤80 years of age will be considered if they show no signs of cognitive or muscle function decline and are fully able to comply with the protocol.

Patients must have experienced intermittent claudication for at least 6 months and have been stable for the past 3 months.

Patients must have peripheral arterial disease, as confirmed by a resting ABI ≥0.40 and <0.90 based on at least one leg as measured using both the dorsal pedis and posterior tibial arteries.

Stenosis of >70% up to total occlusion must be present in the popliteal artery and/or in the tibial peroneal trunk or at least 2 tibial arteries above the ankle without inflow limitation of the popliteal artery. Adequate popliteal inflow is defined as continuous flow from the abdominal aorta, iliac, common femoral and superficial femoral with any stenosis < 50% as determined either by intra-arterial DSA, CTA or Gd CE-MRA.

The screening Gardner treadmill test peak walking times (PWT) must be >1 minute and < 12 minutes and limited by pain in one or both calves.

Hepatic dysfunction as defined either by AST or ALT > 2.0 times the upper limit of normal

Serum creatinine of ≥ 2.5 mg/dl

Proteinuria (urine protein/creatinine ratio > 3)

Antiproliferative drugs (e.g. thalidomide, hydroxyurea)

Radiation therapy

Implanted devices not compatible with strong magnetic fields

Life expectance of less than 1 year

Females who are premenopausal and not sterilized or using adequate birth control or are either pregnant, intend to become pregnant or are nursing

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424866